The call in brief
Read the Q3 2025 earnings summary ↗Adaptive Biotechnologies delivered a standout third quarter of 2025, with the minimal residual disease (MRD) franchise reaching major profitability milestones. Total company revenue rose 102% year-over-year to $94 million, though that figure includes $33.7 million of non-cash revenue from the remaining amortization of prior Genentech payments. Excluding Genentech, MRD revenue grew 52% to $56.8 million, led by clonoSEQ clinical revenue up 83% year-over-year and 18% sequentially. The company delivered over 27,100 clonoSEQ tests (up 38%) across all reimbursed indications and tested more than 19,400 unique patients (up 41%), while U.S. ASP climbed 28% to over $1,340, keeping Adaptive on track toward its $1,700-$1,800 long-term target. Sequencing gross margin expanded 10 points to 66% on NovaSeq X Plus efficiencies and operating leverage, and the MRD business posted $7 million of adjusted EBITDA and turned cash-flow positive ahead of plan. Nine-month cash burn fell 51%, leaving $217 million in cash. Momentum built across EMR integrations (nearly 40% of commercial tests now from integrated accounts), blood-based testing (45% of volume), and favorable NCCN guideline updates in CLL, DLBCL, and myeloma. Management raised full-year MRD revenue guidance to $202-$207 million and lowered opex and cash-burn ranges. In immune medicine, the Genentech partnership concluded, freeing Adaptive from exclusivity, while accelerated AI/ML modeling and a newly selected lead T cell depleting antibody candidate advance future opportunities.
- The MRD business hit major profitability milestones: adjusted EBITDA of $7 million (versus a $6.1 million deficit a year ago) and, ahead of plan, the MRD base business turned cash-flow positive, underscoring the scalability of the model.
- MRD revenue grew 52% year-over-year to $56.8 million (excluding Genentech), with clonoSEQ clinical revenue up an impressive 83% year-over-year and 18% sequentially on broad-based volume gains and higher ASP.
- clonoSEQ delivered over 27,100 tests (up 38% year-over-year, 7% sequentially) across all reimbursed indications, and tested more than 19,400 unique patients, up 41% year-over-year.
- Total company sequencing gross margin improved 10 percentage points year-over-year to 66% (up from 56%), driven by lab operating leverage, stronger pricing, and the NovaSeq X Plus implementation.
- U.S. clonoSEQ ASP rose 28% to over $1,340 per test, keeping the company on track for full-year ASP of $1,300 or higher toward its long-term $1,700-$1,800 target, aided by new payer wins (first commercial DLBCL coverage and two CLL payers, bringing CLL covered lives past 260 million).
- Operating discipline drove cash burn down 51% through the first nine months versus last year, ending the quarter with a strong $217 million cash position, prompting a full-year guidance raise on revenue with lower opex and cash burn.
- EMR integration momentum accelerated with 11 new integrations (six of the top 10 accounts now integrated); nearly 40% of commercial tests came from integrated accounts, and Flatiron integrated accounts grew 17% sequentially.
- The Genentech partnership was concluded following Genentech's internal portfolio prioritization, removing a collaboration and the associated (non-cash) revenue stream, though Adaptive was released from exclusivity and further obligations.
- Immune medicine remained a drag, posting an adjusted EBITDA deficit of $10 million (excluding Genentech) versus $8.7 million a year ago, with pharma and academic services revenue falling to $3.4 million from $5.5 million a year ago.
- Excluding the non-cash Genentech revenue, the total company still ran an adjusted EBITDA loss of $5.8 million and a net loss of $24.2 million for the quarter.
- Emerging competition is entering diffuse large B-cell lymphoma (DLBCL), with more competitors expected in the coming year, requiring Adaptive to defend its lead in a newly contested indication.
- Recent FDA/agency uncertainty around surrogate endpoints introduced risk to MRD's path to broader acceptance as an accelerated-approval endpoint beyond multiple myeloma.
- Q4 guidance implies a sequential deceleration: management flagged holiday-driven seasonality weighing on Q4 volume and ordering, tempering the recent double-digit sequential growth trend.
- New payer coverage wins in DLBCL and CLL will not be reflected in the quarter's results, with the ASP benefit only coming over time as contracting moves through implementation.
Management Commentary
Read the Q3 2025 summary ↗Thank you, Jacinda, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies third-quarter 2025 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the third quarter of 2025. The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing a slide presentation that has been posted to the investor section of our corporate website. During the call, management will make projections and other forward-looking statements within the meaning of federal securities laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as of today. Actual results may differ materially from today's forward-looking statements depending on a number of factors, which are set forth in our public filings with the SEC and listed also in this presentation.
In addition, non-GAAP financial measures will be discussed during the call, and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release. Joining the call today are Chad Robins, our CEO and Co-founder, and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A. With that, I'll turn the call over to Chad. Chad?
Thanks, Karina. Good afternoon, and thank you for joining us on our third-quarter earnings call. I'm pleased to share another quarter of strong execution and accelerating momentum across the business. We delivered meaningful wins, sustained growth, and further strengthened our financial position. Let's now turn to slide three for a summary of this quarter's highlights. The MRD business delivered major profitability milestones. This quarter, adjusted EBITDA was $7 million, reflecting strong sequential growth. Also, this quarter, and ahead of plan, the MRD business became cash flow positive, a significant achievement that underscores the strength and scalability of our model. MRD revenue grew 52% year-over-year, driven by robust increases in clinical volume and ASP. This growth reflects expanding clinical utility and broader integration of MRD testing into patient care. Clinical validation continues to deepen.
The NCCN guidelines were updated again this quarter, this time in CLL, incorporating MRD-guided treatment options, providing more specific direction on testing frequency and supporting clonoSEQ ID testing at diagnosis. Operationally, we're scaling efficiently. With clonoSEQ now running on the NovaSeq X Plus, we're realizing meaningful cost efficiencies and expanding gross margins. Total company sequencing gross margin improved 10 percentage points year-over-year to 66%. Our focus on operating discipline is paying off. Operating expenses remained stable sequentially while cash burn continued to decline. Through the first nine months of the year, we reduced cash burn by 51% versus last year, ending the quarter with a strong cash position of $217 million. Given this performance, we are again updating our full-year guidance to reflect a higher MRD revenue range, lower operating expenses, and a reduced annual cash burn.
Kyle's going to cover the details shortly in his prepared remarks. Let's now turn to slide five for a deeper look at the MRD business. ClonoSEQ clinical revenue had impressive growth of 83% year-over-year and 18% quarter-over-quarter. We saw broad-based volume expansion across all reimbursed indications, delivering over 27,100 tests, up 38% versus prior year and up 7% sequentially. By indication, multiple myeloma remains our largest contributor, accounting for 42% of U.S. clonoSEQ volume, followed by ALL at 32%, CLL at 10%, DLBCL at 9%, and MCL at 5%. This volume growth continues to align with our strategic priorities. First, blood-based testing now represents 45% of volume, achieving our full-year goal ahead of plan. In multiple myeloma, blood-based contribution reached 24%, up from 21% last year.
Second, community-based testing represents 31% of total clonoSEQ volume, with increasing contribution from Flatiron integrated accounts. Third, NHL testing expanded to 15% of total clonoSEQ volume, led by DLBCL and MCL sequential growth. Fourth, ordering HCPs grew 38% year-over-year to more than 4,100, with sequential growth of 9% in academic centers and 12% in community practices. Finally, we tested over 19,400 unique patients in the quarter, a 41% increase year-over-year and 8% sequentially. In addition to volume growth, we saw continued improvement in ASP, with U.S. clonoSEQ ASP increasing to over $1,340 per test. Reinforcing our confidence to achieve full-year average ASP of $1,300 or higher. During the quarter, we achieved several policy wins, including our first large commercial payer coverage in DLBCL and two major payers in CLL, bringing our total CLL covered lives to over 260 million.
We continue to improve cash collections and expand our reimbursement footprint with new payer contracts. Overall, all ASP metrics and contracting initiatives are trending in the right direction, positioning us well to reach our long-term ASP target of $1,700-$1,800 per test. Let's now turn to slide six to review progress on EMR integrations. Our EMR integration efforts continue to gain momentum across both academic and community settings. These integrations are a key driver of volume growth and support two other important strategic initiatives. The first is to build a scalable moat around clonoSEQ, protecting against new entrants and minimizing disruption from account turnover. The second is to maximize clonoSEQ's usage across the care continuum by directly embedding into EMR-driven workflow, which translates into more tests per patient.
Since last quarter, we've completed 11 integrations, seven academic and four community, with six of our top 10 accounts now integrated. Among accounts integrated with Flatiron last quarter, volume in these accounts grew 17% sequentially and now represents 24% of our community volume, up from 20% pre-launch. We're also leveraging integration to enable serial testing plans, with many ordering providers at Flatiron integrated accounts selecting recurring testing at 3, 6, or 12-month intervals. Importantly, nearly 40% of our commercial tests this quarter came from integrated accounts, which continues to outpace growth from non-integrated accounts. Looking ahead, we plan to further expand our EMR footprint and expect continued acceleration from integrated accounts, with fewer ordering discrepancies and deeper account retention. Let's turn to MRD pharma on slide seven. Our MRD pharma business delivered a solid quarter, with revenue up 11% year-over-year, including $6.5 million in milestone revenue.
Multiple myeloma remains the largest contributor to our biopharma portfolio at over 60% of our active trials, followed by CLL at 17% and ALL at 9%. We ended the quarter with a backlog of more than $200 million, reflecting strong partner demand and sustained program activity. ClonoSEQ is most well established as an endpoint in multiple myeloma, where the ODAC and CHMP votes reinforce its role in assessing treatment response and supporting accelerated approvals, particularly in the frontline setting. The momentum is now extending to other lymphoid cancers and driving diversification across our portfolio. Endpoint qualification efforts are underway in CLL and DLBCL, which are already translating into results. 2025 CLL bookings are more than twice what they were last year. Currently, the FDA is accepting MRD as an endpoint on a case-by-case basis in other lymphoid cancers.
Of our 19 ongoing primary endpoint studies, 12 are in multiple myeloma, 6 are in leukemia, and 1 is in MCL. While recent agency news views on surrogate endpoints have introduced some uncertainty, we remain confident MRD will gain broader acceptance as an endpoint for accelerated approval in other lymphoid cancers. As the first and only FDA-cleared MRD assay, clonoSEQ holds a distinct and durable position to capture this market. In summary, MRD is a strong growth engine with multiple levers to increase penetration. Now, let's turn to immune medicine on slide nine. Our immune medicine business is executing across our three strategic priorities. First, we continue to generate large-scale, high-quality proprietary data to develop a digital TCR antigen prediction model. We're making good progress by using our data to train and improve the accuracy of our models.
As we deploy these models, we see promising results in multiple immunology applications. One of these applications included the ability to select the best TCRs to use in cancer cell therapy products in partnership with Genentech. Earlier this quarter, we announced the conclusion of our partnership with Genentech following its internal portfolio prioritization. As a result, Adaptive is released from exclusivity and any further obligations related to this partnership. Importantly, the scientific and technical progress we've made along the way allowed us to significantly accelerate both our data generation and our AI/ML modeling capabilities across multiple use cases. We are deploying our knowledge and infrastructure that we built towards multiple high-value partnership opportunities. Second, for our T cell depletion antibody program, we are on track to establish a preclinical data package in our lead autoimmune indication. This quarter, we selected our lead antibody candidate.
This key milestone is based on robust potency and other functional characterization data that we generated this year. We've also started planning for CMC-tox work, which represents a key step towards IND-enabling studies for this lead T cell depleting antibody in autoimmunity. As we continue to execute on these two focused R&D priorities, we remain financially disciplined and are on track to achieve our 2025 cash burn target between $25 million and $30 million. Now, I'm going to pass it over to Kyle to walk through the financial results and updated full-year guidance. Kyle?
Thanks, Chad. First, I will go over the financial results, including $33.7 million of non-cash revenue recognized this quarter from the remaining amortization of payments previously received from Genentech. Total company revenue for the third quarter was $94 million, representing a 102% increase year-over-year. Total company adjusted EBITDA was $28 million compared to a loss of $14.3 million a year ago. Interest expense from our royalty financing agreement with OrbiMed was $3 million, which was $700,000 higher than interest income. Net income from the quarter was $9.5 million. Now, and as shown on slide 10, the revenue and adjusted EBITDA figures, which I will be discussing forward, are presented, excluding all non-cash revenue from Genentech in all periods presented. Looking at this quarter's performance on slide 10, MRD revenue grew 52% year-over-year to $56.8 million, with clinical and pharma contributing 67% and 33% respectively.
ClonoSEQ test volume, including international, increased 38% versus last year to 27,111 tests delivered. U.S. ASP grew 28% to over $1,340, reflecting continued strength in cash collections and improved pricing through our various contracting initiatives. MRD pharma revenue grew 11% year-over-year, inclusive of $6.5 million in milestones. Immune medicine revenue from pharma and academic services was $3.4 million versus $5.5 million a year ago. Turning to gross margins and expenses. Total company gross margin, again excluding Genentech revenue, was 70%. Sequencing gross margin, which excludes MRD milestones, was 66%, up from 56% a year ago. This improvement was driven by operating leverage in the lab from higher volumes, stronger pricing across both clinical and pharma, and efficiency gains from the NovaSeq X Plus implementation. Total operating expenses, including cost of revenue, was $83.7 million, up 6% year-over-year and flat sequentially.
The year-over-year increase was primarily driven by higher SG&A expenses related to our expected EMR and reimbursement efforts and higher cost of revenue from volume growth, partially offset by lower R&D expenses. Turning to profitability. As shown on the segment reporting table at the bottom of the slide, the MRD business delivered positive adjusted EBITDA of $7 million compared to a deficit of $6.1 million a year ago. Immune medicine adjusted EBITDA deficit, again excluding the Genentech revenue, was $10 million versus $8.7 million in Q3 of last year. At the total company level, adjusted EBITDA, excluding Genentech, was a loss of $5.8 million compared to a $17.8 million loss a year ago. Total company net loss for the quarter was $24.2 million, again excluding Genentech. Turning to our full-year 2025 updated guidance on slide 11.
We are raising our full-year MRD revenue guidance to a range of $202 million-$207 million, up from the prior range of $190 million-$200 million. This increase reflects stronger than expected clinical revenue performance in Q3 and higher MRD milestone revenue for the year. With sustained clinical volume momentum, we now expect to deliver approximately 104,000 tests for the year, exceeding our prior growth target of 35% over 2024. We also expect MRD milestone revenue between $18 million and $19 million, up from our previous $14 million-$15 million range. Overall, this outlook implies 39%-42% total MRD revenue growth year-over-year and 38%-42% growth for the MRD-based business, which excludes milestones at the midpoint. We are also tightening and lowering the top end of our total company operating expense guidance, including cost of revenue, to $335 million-$340 million, from our previous range of $335 million-$345 million.
We continue to expect roughly 69% of expenses from MRD, 23% from immune medicine, and the remainder from unallocated corporate costs. Further, we are also narrowing and lowering our full-year company cash burn guidance to $45 million-$50 million from the prior $45 million-$55 million range, driven primarily by higher MRD revenue. We expect approximately 15% cash burn from MRD, still anticipate $25 million-$30 million from immune medicine, and the balance from unallocated corporate costs. It's encouraging to see the MRD business generate positive cash flows, achieve positive adjusted EBITDA on the base business, all while continuing meaningful top-line growth. With that, I'll hand it back over to Chad.
Thanks, Kyle. Our results this year highlight the strength of our strategy and the discipline of our execution. MRD is now a profitable scaling business that is delivering consistent growth and margin expansion, and immune medicine continues to advance key R&D programs and unlock new partnership opportunities for future growth. We're confident in our trajectory and are well-positioned to finish the year strong, with a solid foundation for long-term value creation. With that, I'd like to now turn the call back over to the operator and open it up for questions.
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